The FDA has approved daratumumab (Darzalex) for use in combination with carfilzomib (Kyprolis) and dexamethasone (DKd) to treat adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 previous lines of therapy, according to the Janssen Pharmaceutical Companies of Johnson & Johnson, the developer of the agent.
Specifically, daratumumab was approved in combination with 2 carfilzomib dosing regimens, including 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the phase 3 CANDOR and phase 1b EQUULEUS studies. This approval represents the first-ever approval of a CD38 antibody with carfilzomib.
“The significant increase in progression-free survival (PFS) seen among patients receiving the DKd regimen supports the use of this new combination for patients with relapsed and refractory multiple myeloma. We continue to advance effective regimens for the most critical patients who have already relapsed,” Saad Z. Usmani, MD, division chief of Plasma Cell Disorders at Atrium Health’s Levine Cancer Institute and principal investigator of the CANDOR study, said in a press release. “The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug-based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed.”
The open-label, phase 3 CANDOR study randomized 466 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy to receive either the DKd triplet or carfilzomib and dexamethasone (Kd). Of note, the twice weekly dose of carfilzomib was administered in this study.